MAUDE Adverse Event Report: ACCLARENT, INC. TRUDI SUCTION, 0 - 1PK; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT

Catalog Number	TDNS000Z
Medical Device Problem Code	Incorrect Interpretation of Signal (1543)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that during a functional endoscopic sinus surgery (fess), there was an inaccurate suction with about 4-5mm when using a trudi suction, 0 - 1pk (tdns000z, 2207120), registered the patient twice, but the issue remained.The physician stopped using navigation and completed without navigation.The caller stated that on that day there was nothing else done.No non acclarent devices were used.The acclarent device(s) did not function as expected.There was no allegation that a death or serious injury occurred due to the use of the product.There was no report of the patient requiring medical intervention as a result the alleged product issue.Additional event information received on 30-apr-2024 indicated the patient tracker moved or the patient tracker cable under tension in relation to this event, however it was fixed, and we re-registered.The computed tomography (ct) scan was good.Unable to specified how many slices did the ct scan contained, but it was sub 2mm.There was no ferromagnetic material placed within the trudi zone.The emitter pad did not move nor did the patient move.There was no other device¿s shaft in proximity to an emitter pad¿s transmitter.The trudi suction, 0 was reprocessed 28 times.The device was sterilized per the instructions for use (ifu).When the accuracy issue was observed, the icon displayed green on the trudi system monitor.There was no other error message on the trudi nav monitor for the device.The inaccuracy was determined by the physician¿s report.
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.E.1: the name, phone and email address of the initial reporter are not available / reported.The device is not available to be returned, therefore, no further investigation can be performed.A manufacturing record evaluation was performed, and no non-conformances related to the complaint was found during the review.With the information available and without the product available for analysis, the reported customer complaint could not be confirmed.Based on the manufacturing record evaluation, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be determined; however, there are circumstances of the procedure that may have contributed to the reported failure.The instructions for use (ifu) states that before use, confirm the trudi¿ suction¿s location accuracy by checking the displayed position of the trudi¿ suction on several clearly identifiable anatomical structures.If the deviation is significant and is not resolved by repeating the registration of the ct scan on the system, do not use the trudi¿ suction.Multiple attempts to obtain additional information were unsuccessful.If information is provided at a later date, the file will be reopened and processed accordingly.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by acclarent, or its employees that the report constitutes an admission that the product, acclarent, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: TRUDI SUCTION, 0 - 1PK
• Common Device Name: EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): ACCLARENT, INC.; 31 technology drive; irvine CA 92618
• Manufacturer (Section G): VIANT MEDICAL; 45 lexington drive; laconia NH 03246
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 19361583
• Report Number: 3005172759-2024-00060
• Device Sequence Number: 3851637
• Product Code: PGW
• UDI-Device Identifier: 10705031245877
• UDI-Public: 10705031245877
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K180948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: TDNS000Z
• Device Lot Number: 2207120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown